Study to Explore the Safety and Feasibility of Allogeneic Young Plasma Infusion in Older Adults

Withdrawn before enrolling · Early Phase 1

Conditions studied: Frailty Syndrome, Heart Failure

In brief

Evaluate the feasibility of administering plasma (PF24) acquired from donors of a young chronological age intravenously to older adults at WFBMC while also exploring its effects on age-related functional decline

Key facts

Study ID

NCT04241159

Run by

Wake Forest University Health Sciences

People needed

0

Starts

2020-05-01

Expected to finish

2020-08-01

Last updated by the study team

2020-05-22

Who can join

Age: 65 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• English speaking elderly males and females, aged 65-80 years, referred by the Gerontology Department and the Cardiology Clinic of the Wake Forest Baptist Health Sticht Center for Aging.
• a score of 3 or greater (at least frail status) as demonstrated by the Fried Frailty criteria.

You may not qualify if…

• Unable or unwilling to give informed consent in either study group
• Current psychiatric disorder not currently under control or being adequately treated
• Current consumption of more than 14 alcoholic drinks per week
• Self-reported inability to walk across a small room
• Residence in a nursing home
• Previous MOCA score below 21
• Difficulty in communication with study personnel due to speech or hearing problems
• Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
• Elective surgery, planned prior to signing consent
• Severe osteoarthritis
• Rheumatoid arthritis
• Severe B/L hip, knee, or hand pain (>7/10 on pain scale)
• Cancer requiring treatment in the past three years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis (e.g., Stage 1 cervical cancer)
• Pulmonary disease including VQ mismatch/diffusion limitation, diminished inspired O2, hypoventilation, pulmonary fibrosis, or sarcoidosis
• Current tobacco use (smoke/chew)
• Currently prescribed corticosteroids
• Patients taking nucleoside analogues (Zebularine, 5-azaC, Decitabine)
• Patients on non-nucleoside analogues (Procaine, procainamide, hydralazine)
• History of an inherited bleeding disorder or vitamin K deficiency
• Cardiovascular disease (excluding HFpEF), clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator or uncontrolled angina.
• Parkinson's disease or other serious neurological disorder
• MMS score < 18
• Renal disease (any stage, inappropriate for age; Cr Cl < 60)
• Hypoalbuminemia, with serum albumin level < 3.5 g/dL
• History of IgA deficiency

Where it is running

• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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